Method and apparatus for assisting deglutition

ABSTRACT

Methods and systems for artificially stimulating user deglutition without substantial aspiration are provided. Methods and systems include artificially stimulating user deglutition according to various specialized programs, including passive user secretion maintenance programs, active feeding programs, proprioceptive feedback programs, and others.

BACKGROUND

The present invention relates to systems and methods for assistingdeglutition, and more particularly to systems and methods forstimulating deglutition musculature in order to reduce effects ofdysphagia.

The condition of having an inability to swallow is generally describedas “dysphagia.” Dysphagia is commonly associated with ailments such asstrokes, neurodegenerative diseases, brain tumors, respiratorydisorders, and others. In some forms, dysphagia results in aspirationduring “deglutition,” the act of swallowing. Aspiration duringdeglutition is of great concern as it increases the risk of aspirationpneumonia. In particular, there is evidence that aspiration pneumoniainflicts about a 20% death rate in the first year after a stroke andabout a 10% to 15% death rate each year thereafter. Traditionaltreatments for dysphagia have employed either temporary feeding througha nasogastric tube or enteric feeding through a stoma to the stomach inchronic cases.

Techniques of electrical stimulation of electrically excitable tissuewithin the body of a living subject have been developed utilizingstimulating electrodes and a signal generator to supply electricalcharges in a controlled or predetermined manner. PCT App. Pub. WO2004/028433 (“Ludlow”) (entitled “Methods and Devices for IntramuscularStimulation of Upper Airways and Swallowing Muscle Groups;” publishedApr. 8, 2004) describes stimulation of muscles within a neck region of ahuman subject for the purpose of causing muscles to react as aswallowing effect. More specifically, Ludlow describes inducement ofswallowing in a subject's body by implanting electrodes in two or moremuscles of the upper airway musculature and connecting the electrodeswith a signal generator that provides coordinated control signals. Othertechniques and methods of artificial stimulation using transcutaneous,non-implanted systems are disclosed in U.S. Pat. Nos. 5,725,564;5,891,185; 5,987,359; 6,104,958; and 6,198,970, all to Freed et al.

SUMMARY

Some aspects relate to a method of stimulating user deglutition withoutsubstantial aspiration, including use of a passive user secretionmaintenance program. The method includes providing a portable systemborn by a user for controlling a component of a complete swallowing act,the system including a controller, a signal generator, and an electrodearray including at least one electrode. The signal generator is incommunication with the electrode array. The electrode array issubcutaneously positioned in stimulating communication with deglutitionmusculature. User deglutition is artificially stimulated via the signalgenerator and electrode array according to a passive user secretionmaintenance program adapted to automatically, periodically stimulatedeglutition of user secretions without substantial aspiration of theuser secretions.

Other aspects relate to a method of stimulating user deglutition withoutsubstantial aspiration including use of a plurality of specializeddeglutition programs. The method includes providing a portable systemborn by a user for controlling a component of deglutition, the systemincluding a controller, at least one stimulating electrode, and a signalgenerator. The at least one stimulating electrode is subcutaneouslypositioned in stimulating communication with deglutition musculature. Adesired deglutition program is selected from a plurality of specializedprograms maintained by the controller based upon a characteristic of abolus to be consumed by the user. The system is operated according tothe selected deglutition program.

Yet other aspects relate to a method of stimulating user deglutitionwithout substantial aspiration. The method includes providing a portablesystem born by a user for controlling at least a component ofdeglutition, the system including a controller, an electrode array, anda signal generator in communication with the electrode array. A firstportion of the electrode array is subcutaneously positioned instimulating communication with deglutition musculature, whereas a secondportion of the electrode array is subcutaneously positioned instimulating communication with sensory mucosa of at least one of a mouthand a throat of the user. The sensory mucosa is stimulated with theelectrode array to provide the user with tactile, sensory feedback. Thedeglutition musculature is stimulated with the electrode array to causeuser deglutition without substantial aspiration.

Yet other aspects relate to a method of stimulating user deglutitionwithout substantial aspiration. The method includes providing a portablesystem born by a user for controlling at least a component ofdeglutition, the system including a controller, a signal generator, andan electrode array including at least one electrode. The electrode arrayis subcutaneously positioned in stimulating communication withdeglutition musculature. The deglutition musculature is stimulated viathe electrode array with a subthreshold, baseline signal prior to userdeglutition. The deglutition musculature is stimulated via the electrodearray with a stimulating signal following stimulation with thesubthreshold, baseline signal. In particular, the stimulating signalcauses a component of user deglutition to be artificially stimulated.

Yet other aspects relate to a system for assisting user deglutitionwithout substantial aspiration. The system includes an electrode arrayadapted to be subcutaneously positioned in stimulating communicationwith deglutition musculature. The system also includes a sensor arrayadapted to be subcutaneously positioned for providing deglutitioninformation. A signal generator is electronically connected to theelectrode array for providing a stimulating signal to the electrodearray. A controller is also provided and is electronically connected tothe sensor array and the signal generator, such that the controllerreceives the deglutition information and prompts operation of the signalgenerator to cause a component of deglutition to occur. In particular,the controller is adapted to actively modify the stimulating signaldelivered by the signal generator based upon the received deglutitioninformation.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a system for assisting deglutitionaccording to some embodiments.

FIG. 2 shows an epimysial electrode according to some embodiments.

FIG. 3 shows a nerve cuff electrode according to some embodiments.

FIG. 4 is a schematic view of the system of FIG. 1 including aself-contained electrode according to some embodiments.

FIG. 5A is a schematic view of bodily components associated withdeglutition.

FIG. 5B is a schematic view of a hylayrngeal complex and associatedbodily components associated with deglutition.

FIG. 6 is a schematic view of an implantable system for assistingdeglutition according to some embodiments.

FIG. 7 illustrates several muscle activation patterns according to someembodiments.

FIG. 8 shows an electrode array of the system of FIG. 1 in stimulatingcommunication with deglutition musculature via a plurality of nervesaccording to some embodiments.

DETAILED DESCRIPTION

In order to provide a better understanding of various embodiments, thefollowing description has been formatted with several headings. However,it is to be understood that such headings are not intended as limiting,and that description is intended to be read as a whole, as a cumulativenarrative of various embodiments with interrelating features whereappropriate. With that in mind, descriptions of the following, generaltopics are provided: Deglutition Assistance Systems Overview; Overviewof Deglutition; Artificial Deglutition Muscle Stimulation via Nerves;Muscle Activation Patterns and Associated Stimulation Patterns; SingleMuscle Stimulation and Select Muscle Group Stimulation; StimulationProgram Initiation and Selection; and System Feedback.

Deglutition Assistance Systems Overview

FIG. 1 is a schematic view of a system 20 for assisting deglutition. Thesystem 20 includes a controller 22, a signal generator 24, an electrodearray 26 including at least one electrode, a sensor array 28 includingat least one sensor, and a power source 30. In some embodiments, variouscomponents of the system 20 are maintained in an implantable housing 32(FIG. 6), which is optionally substantially similar to a pacemaker“can,” with an external switch or sensor (FIG. 6) optionally includedfor activating the system 20. As indicated generally by dotted lines,the various aspects of the system 20 communicate with one another, suchcommunication being accomplished via a variety of mechanisms. Forexample, the components are optionally in direct, electricalcommunication; radio frequency communication; magnetic communication;optical communication; sonic communication; combinations thereof, andothers.

The system 20 is generally adapted to control deglutition musculature.In some embodiments, the system 20 is portable and adapted to be born bya user, for example a chronic dysphagia sufferer, for extended periodsof time. The controller 22, the signal generator 24, the electrode array26, the sensor array 28, and/or the power source 30, or portionsthereof, are provided as separate, distinct components; as partiallyintegrated components; or as fully integrated components as desired. Forexample, some embodiments include one or more integrated electrodeshaving processing, signal generating, external communicating, and/orsensing capabilities, one or more of which are fully or partiallyintegrated into the integrated electrode(s).

In some embodiments, the controller 22 includes a microprocessor, ahardwired circuit, or other appropriate means for controlling variousaspects of the system 20. In particular, the controller 22 operates thesignal generator 24 and/or receives information from various sources,such as the sensor array 28. In some embodiments, the controller 22 isadapted to store a stimulation program or programs and operate thesignal generator 24 according to the stimulation program(s). Stimulationprograms include predetermined, set programs, for example hardwired intothe controller 22, but can also include adaptive, dynamic programs, forexample software that adapts artificial deglutition stimulationaccording to various inputs, such as input from the sensor array 28.

It follows that, in some embodiments, the controller 22 selects betweenvarious programs and/or actively modifies a stimulation programaccording to various inputs, such as information received from a user,information received from the sensor array 28, information received fromthe signal generator 24, information received from the electrode array26, information received from a remote processor (not shown), and/orinformation received from a technician or surgeon, for example.

The signal generator 24 is in communication with the electrode array 26and is adapted to provide one or more stimulating signals to theelectrode array 26. In some embodiments, the simulating signalscommunicate stimulating energy, such as electrical current pulses, tothe electrode array 26 in order to activate deglutition musculature. Asdescribed in greater detail below, the signal generator 24 optionallyincludes circuitry and/or other implantable components for outputtingelectrical pulses through electrical leads to the electrode array 26.For example, the stimulating signals are optionally a series ofoverlapping, electrical current pulse trains communicated to theelectrode array 26 and ultimately to deglutition musculature. It is alsocontemplated that the signal generator 24 optionally communicates powerto the electrode array 26 via other mechanisms than electricalconnection, for example radiofrequency power transmission and/ormagnetic power transmission.

Additionally, or alternatively, signals from the signal generator 24 canbe otherwise communicative in nature, for example, communicatingstimulation program information, patient information, and other types ofinformation. In some embodiments, the signal generator 24 includes aradio frequency transmitter communicating with a self-containedelectrode acting as a receiver, i.e., an electrode that is notphysically “wired” to a separate signal generator via electrical leadsor other means. In particular, the self-contained electrode receives theradio frequency transmission as a source of power and/or as a controlsignal for timing delivery of stimulating energy to deglutitionmusculature. It should also be noted that in some embodiments, theself-contained electrodes include an associated signal generator forproviding stimulating signals to the particular self-containedelectrode. For reference, embodiments of self-contained electrodes andvarious examples of stimulation signal patterns and stimulation programsare subsequently described in association with methods of artificiallystimulating deglutition.

As previously alluded to, unless specified otherwise, the controller 22and the signal generator 24 (as well as other components of the system20) are configured as separate, distinct components; partiallyintegrated components; or fully integrated components as desired. As oneexample, a combined controller 22 and signal generator 24 include ashared processor or processors providing a stimulating signal to theelectrode array 26 in the form of an electrical current output or otherappropriate output from the processor. Thus, in the absence of limitinglanguage, such as “wherein the signal generator 24 and the controller 22are separate, distinct components,” “the signal generator 24 being apartfrom the controller 22,” or alternatively “wherein the signal generator24 and the controller 22 are fully integrated,” for example, it iscontemplated that the controller 22 and signal generator 24 are not solimited.

The electrode array 26 includes one or more electrodes, such as a firstelectrode 26 a, a second electrode 26 b, and a third electrode 26 c. Theelectrode array 26 is adapted be in stimulating communication withdeglutition musculature, for example via subcutaneous, intramuscularplacement; subcutaneous, exterior placement on a muscle surface; and/orsubcutaneous implantation and association with one or more nervescontrolling deglutition musculature. Alternatively, one or moreelectrodes of the electrode array 26 are adapted for percutaneousapplication or application external to skin, for example.

In some embodiments, the electrode array 26 includes one or more of thefollowing types and/or categories of electrodes: epimysial electrodes;intramuscular electrodes, such as Peterson electrodes; nerve cuffelectrodes; self-contained electrodes; monopolar electrodes; bipolarelectrodes; multi-contact electrodes; and/or other known electrodetypes/categories and combinations thereof. As described in greaterdetail below, in some embodiments, the electrode array 26 includes oneor more associated flexible, extensible electrical leads suited for usein deglutition stimulation applications, such as those described inco-pending U.S. application Ser. No. 11/413,316 (entitled “ImplantableMedical Leads And Lead Assemblies With Improved Flexibility AndExtensibility To Facilitate Body Movements”); Ser. No. 11/413,435(entitled “Methods For Customizing Implantable Medical Lead AssembliesWith Improved Flexibility And Extensibility”); Ser. No. 11/413,437(entitled “Implantable Medical Assemblies With Improved Flexibility,Extensibility, And Positionability With Branched Structures”); and Ser.No. 11/413,440 (entitled “Implantable Medical Leads And Lead AssembliesWith Improved Flexibility And Extensibility And Having A SubstantiallyTwo-Dimensional Nature”); all filed on Apr. 28, 2006 and the contents ofeach of which are incorporated herein by reference (cumulativelyreferred to herein as “the Extensible Lead Applications”).

For general reference purposes, FIG. 2 shows an epimysial electrode 33useful as, or as part of, the electrode array 26 (FIG. 1) in accordancewith some embodiments. The epimysial electrode 33 includes an insulatedhousing 34 and one or more contacts 36 maintained by the insulatedhousing 34. An electrical lead 38 is connected to the epimysialelectrode 33 to provide an electrical conduit to each contact 36 on anindividual or ganged basis as desired. In some embodiments, theepimysial electrode 33 includes a single contact 36 and is monopolar toreduce overall size and/or provide increased overall structuralflexibility.

The epimysial electrode 33 is adapted to be secured to a muscle surface,for example by sewing or other appropriate means. In some embodiments,the epimysial electrode 33 helps avoid problems associated withintramuscular electrodes, such as plunging intramuscular electrodes intotissue located behind a target muscle. For example, the epimysialelectrode 33 can exhibit less tissue reaction than intramuscularelectrodes and is well-suited for use with what can be consideredrelatively thin deglutition muscles according to some embodiments.Examples of epimysial electrodes can be found in U.S. Pat. No.5,843,147, issued Dec. 1, 1998, to Testerman et al., and entitled“Implantable Eyelid Electrode and Method of Implanting the Same,” thecontents of which are incorporated herein by reference.

FIG. 3 is a simplified view of a nerve cuff electrode 40 useful as, oras part of, the electrode array 26 (FIG. 1). The nerve cuff electrode 40includes a plurality of radially disposed contacts 42 maintained by atubular, insulated housing 44. The nerve cuff electrode 40 is connectedto an electrical lead 46 providing an electrical conduit to each of theplurality of contacts 42, for activation either individually or on aganged basis as appropriate. In general terms, the nerve cuff electrode40 is adapted to be disposed about, and in stimulating communicationwith nerves to deliver stimulating energy to the nerves. In someembodiments, the nerve cuff electrode 40 is substantially U-shaped, forexample as described in U.S. Pat. No. 5,344,438, issued Sep. 6, 1994 toTesterman et al., and entitled “Cuff Electrode,” the contents of whichare incorporated herein by reference. Other examples of suitable nervecuff electrodes include the self-sizing electrode cuffs described inU.S. Pat. No. 4,603,624, issued Jul. 29, 1986, to Naples et al., andentitled “Cuff, Method of Manufacture, and Method of Installation.” Asdescribed in greater detail below, the nerve cuff electrode 40 isadapted to selectively stimulate muscles controlled by nerves in someembodiments. For example, the nerve cuff electrode 40 is optionallyadapted to allow individual energizing of the radially disposed contacts42 using a multi-channel signal generator, such as the signal generator24 (FIG. 1), in order to effectuate current steering techniques, or isotherwise adapted to selectively stimulate nerve fascicles of a nerve asdesired.

Returning to FIG. 1, as used herein, “self-contained electrodes” referto electrodes that are not “hardwired” to the signal generator 24 and/orinclude their own signal generator, such as those described in theSchulman Patents subsequently referenced herein. For example, the signalgenerator 24 optionally communicates and/or supplies power to theelectrode array 26 via radiofrequency transmission and/or magnetictransmission mechanisms. Still further, in some embodiments,self-contained electrodes, or alternately “hardwired” electrodes ifdesired, are optionally integrated with various control/operationcomponents, such as a signal generator and/or processor for controllingelectrode activation, a power source for providing power to activate theelectrode, and one or more contacts for receiving/conveying stimulatingenergy.

FIG. 4 is a schematic view of an embodiment where the system 20 includesat least one self-contained electrode 48 useful as, or as a part of, theelectrode array 26. The self-contained electrode 48 is shown receiving asignal S, for example a radiofrequency and/or magnetic signal, from atransmitter (not shown) provided with the system 20. In someembodiments, the self-contained electrode 48 is an implantablemicrostimulator, such as those described in U.S. Pat. No. 5,193,539,issued Mar. 16, 1993, to Schulman et al., and entitled “ImplantableMicrostimulator;” U.S. Pat. No. 5,193,540, issued Mar. 16, 1993, toSchulman et al., and entitled, “Structure and Method of Manufacture ofan Implantable Microstimulator;” and U.S. Pat. No. 5,324,316, issuedJun. 28, 1994 to Schulman et al., and entitled “ImplantableMicrostimulator” (collectively referred to herein as “the SchulmanPatents”), the contents of all of which are incorporated herein byreference. For example, the controller 22 and/or the signal generator 24optionally include an electrical coil (not shown) and are providedexternally to a dysphagia sufferer, with the self-contained electrode 48being subcutaneously implanted. In some embodiments, the system 20 isconfigured such that the self-contained electrode 48 receives powerand/or stimulation commands through the signal S, for example with thesignal S being an AC magnetic link established between the signalgenerator 24 and the self-contained electrode 48 using the externalelectrical coil.

Returning to FIG. 1, the sensor array 28 includes one or more sensors,such as a first sensor 28 a, a second sensor 28 b, and a third sensor 28c. The sensor array 28 is adapted to provide information relating todeglutition and/or the system 20. The sensor array 28 includes sensorsadapted for subcutaneous use; exterior placement, for example on skin orhair; and/or percutaneous placement as appropriate. In some embodiments,the sensor array 28 includes one or more force, movement, pressure,and/or position sensors, such as accelerometers; force gauges, forexample strain gauges; EMG sensors; displacement sensors, for examplesensors using piezo crystals to provide ultrasonic generating/sensingtransducers; pressure sensors; and others.

Operating requirements of the various sensors, for example the sensors28 a-28 c, are better understood with reference to various embodimentmethods of artificially stimulating deglutition using the system 20 thatfollow. Examples of suitable sensors and/or sensors which are suitablyadapted for use with the system 20 can be found, for example, in U.S.Pat. No. 7,037,266, issued May 2, 2006 to inventors Ferek-Petric et al.and entitled “Ultrasound Methods and Implantable Medical Devices UsingSame,” the contents of which are incorporated herein by reference.

As previously referenced, the power source 30 is a single component ormultiple components, and is provided separately and distinct from othercomponents of the system 20 or as an integrated part of other componentsof the system 20. The power source 30 is optionally a chemical battery,a capacitor, or other appropriate means for powering the system 20. Insome embodiments, the power source 30 is adapted to be safely implantedinto a living creature, for example a person suffering from dysphagia.

Overview of Deglutition

With the understanding provided by the foregoing, it is useful to givesome background on various aspects of deglutition, the act ofswallowing, as well as various body parts associated with deglutitionprior to describing additional specifics of the system 20 and methods ofuse thereof. FIG. 5A is a generalized, schematic view of bodilycomponents 50 associated with deglutition. In turn, FIG. 5B is a second,generalized schematic view of some of the bodily components 50 of FIG.5A presented for additional understanding. Generally speaking, thebodily components 50 are described with reference to human anatomy.However, it is contemplated that, though human anatomy may not beidentical to that of other organisms, similar concepts to thosedescribed herein are applicable to other living organisms, such asmonkeys, cats, dogs, horses, reptiles, or other animals, for example.Regardless, in general terms the bodily components 50 generally includeone or more nerves 52, one or more deglutition muscles 54, and one ormore deglutition structures 56. As described in greater detail, thenerves 52 perform motor functionality by directly stimulating thedeglutition muscles 54 and/or providing sensory activation of thedeglutition muscles 54, including via sensory mucosa or muscular sensoryendings. In turn, the deglutition muscles 54 move the deglutitionstructures 56 to complete deglutition, or otherwise effectuate acomplete swallowing act.

By way of background, a complete act of swallowing can be broken downinto several, basic stages—an oral stage, a pharyngeal stage, and anesophageal stage. Each stage includes a series of movements foreffectuating deglutition of a bolus. As used herein, “bolus” refers toany substance to be swallowed, including liquids and solids, unlessindicated otherwise. In cases of dysphagia, there is insufficient muscleactivity (e.g., timing, type, or amount of activity) during one or morestages of deglutition, such that deglutition is defective. Often times,defective deglutition results in aspiration of the bolus or a portionthereof. At times, a particular case of dysphagia affects swallowing indifferent manners and/or to different extents according to theindividual, including the particular swallowing structures/musclesaffected, and/or according to a type/size/consistency of the bolus beingswallowed.

Generally, the oral stage entails voluntary control of oral structures,for example controlling the anterior position of the soft palate. Duringthe oral stage, the bolus is typically pushed back in the oral cavitywith the tongue. An end portion of the oral stage is generally indicatedby the bolus passing the anterior faucial arches of a throat. Typically,the pharyngeal phase commences as an involuntary reflex initiated by theend portion of the oral stage. It should be noted that portions of thethree stages often overlap. In some cases of dysphagia, insufficientmovement during the oral stage results in a delay of initiation of abeginning portion of the pharyngeal phase, which, in turn, can lead toaspiration during swallowing.

The beginning portion of the pharyngeal stage typically includes usingmuscles of the hyolaryngeal complex that control hyoid movement andlaryngeal elevation to raise or lift the hyolaryngeal complex and moveit forward in an anterior direction. Normally, as a part of thepharyngeal stage, thyroarytenoid and ventricular cords are closed toform a velopharyngeal seal. The epiglottis is tilted and an upperesophageal sphincter (UES) is relaxed, opening the esophagus. The UES islocated in a cricopharyngeal region and includes a cricopharyngeusmuscle which is attached to cricoid cartilage. In some cases ofdysphagia there is insufficient lifting/forward movement of thehyolaryngeal complex, insufficient tilting of the epiglottis, and/orinsufficient relaxation/opening of the UES, all of which can contributeto aspiration and/or other defects in a complete swallowing act.

A beginning portion of the esophageal stage is typically initiated asthe upper esophageal sphincter (UES) opens. The bolus is transferreddown the esophagus by a series of peristaltic wave contractions whichare typically initiated during the pharyngeal stage. The boluseventually works its way to the inferior esophageal sphincter and entersthe stomach. In some cases of dysphagia, the cricopharyngeal openingremains lax following the pharyngeal stage, and does not sufficientlyconstrict. This can also result in some material remaining in thepharynx, raising the risk of subsequently aspirating the remainingmaterial.

With the above overview in mind, the bodily components 50 and relativeinteractions between the bodily components 50 are described in greaterdetail, beginning with the nerves 52. The nerves 52 include a pluralityof nerves, such as a first nerve 52 a, a second nerve 52 b, and a thirdnerve 52 c. In general terms, the nerves 52 stimulate activation of thedeglutition muscles 54 and/or provide sensory feed back relating todeglutition, with each of the nerves 52 a, 52 b, 52 c being formed of aplurality of nerve fibers, such nerve fibers being grouped into nervefascicles. For example, the first nerve 52 a includes a first pluralityof nerve fascicles 60, such as a first nerve fascicle 60 a, a secondnerve fascicle 60 b, a third fascicle 60 c, and a fourth fascicle 60 d.The second nerve 52 b also includes a second plurality of nervefascicles 62, such as a fifth nerve fascicle 62 a and a sixth nervefascicle 62 b. As described in greater detail below, when associatedwith muscular motor response, the nerve fascicles are “tied” to one ormore of the deglutition muscles 54, such that a particular nervefascicle or group of nerve fascicles stimulates or otherwise causesactivation of a particular muscle or group of muscles. Some embodimentsinclude selectively stimulating one or more nerve fascicles of aparticular nerve to selectively stimulate deglutition muscles associatedwith the particular nerve.

The first nerve 52 a is a hypoglossal nerve with the nerve fascicles 60activating the geniohyoid, hyoglossus, thyrohyoid, omohyoid,sternothyroid, sternohyoid, genioglossus, and/or styloglossus muscles,for example. In turn, the second nerve 52 b is a mylohyoid nerve (froman inferior alveolar nerve) activating the mylohyoid muscle and/or adigastric muscle, for example. The third nerve 52 c is a cervicalisnerve activating one or more associated deglutition muscles 54. Althoughspecific examples for the first, second, and third nerves 52 a-52 c havebeen provided, it should be understood that the nerves 52 are any of thenerves (including nerve branches, nerve roots, nerve rootlets, etc.)that stimulate musculature associated with deglutition (motor function)and/or carry sensory signals (sensory function). For example, the nerves52 are selected from one or more of a vagus, hypoglossal, mylohyoid,glossopharyngeus, laryngeal, superior laryngeal, recurrent laryngeal,facial, C1 trigeminal, mandibular, inferior alveolar, and cervicalnerves, including the ansa cervicalis, and other nerves.

With reference between FIG. 5A, FIG. 5B, and FIG. 8, and as previouslyreferenced, the deglutition muscles 54 cause movements corresponding tovarious stages of deglutition. For reference FIG. 5B represents severalof the deglutition muscles 54 according to associated directions theymove the hyolaryngeal complex 64. The deglutition muscles 54 aregenerally any of the plurality of muscles causing movements associatedwith components of deglutition, including muscles associated with anyone or more of the oral, pharyngeal, and esophageal stages ofdeglutition. For illustrative purposes, a first muscle 54 a, a secondmuscle 54 b, a third muscle 54 c, a fourth muscle 54 d, a fifth muscle54 e, a sixth muscle 54 f, a seventh muscle 54 g an eighth muscle 54 h,and a ninth muscle 54 i are described. In particular, the muscles 54a-54 i are mylohyoid, geniohyoid, thyrohyoid, anterior belly of adigastric, hyoglossus, stylohyoid, genioglossus, sternohyoid, andsternothyroid, respectively.

Though specific ones of the deglutition muscles 54 are listed above, itshould be understood that the deglutition muscles 54 also include anyone or more of the muscles or muscle groupings selected from thefollowing, non-exclusive list: muscles supporting the larynx and hyoidbone; intrinsic laryngeal muscles, extrinsic laryngeal muscles,posterior intrinsic muscles of the tongue, hyoglossus, genioglossus,thyrohyoid, constrictor pharyngis superior, constrictor pharyngismedius, constrictor pharyngis inferior, cricopharyngeus (UES),digastricus, cricoarytenoid lateralis, geniohyoid, levator velipalatini, mylohyoid, omohyoid, palatoglossus, palatopharyngeus,sternohyoid, sternothyroid, styloglossus, stylohyoid, stylopharyngeus,tensor veli palatine, thyroarytenoid inferior, thyroarytenoid superior,and others. For reference, where a bilateral pair of muscles isimplicated, the term “a single deglutition muscle,” for example, isindicative of a unilateral one of such a bilateral muscle pair.

The deglutition structures 56 are formed of bone, cartilaginous matter,tissue, muscles (including one or more of the deglutition muscles 54),and/or other materials. In general terms, the deglutition structures 56include the UES, the epiglottis, the hyoid, and other components of thelarynx and/or the pharynx, for example, as well as other deglutitionstructures.

With reference to the schematic view of FIG. 5A, the deglutitionstructures 56 include a hyolaryngeal complex 64, components of which arealso presented in FIG. 5B. As used herein, the term “hyolaryngealcomplex” refers to a deglutition structure of the neck including thelarynx, the hyoid, and associated deglutition muscles. With reference toFIG. 5A, the hyolaryngeal complex 64 includes a hyoid 70, an epiglottis72, a UES 76, and lower laryngeal cartilages 78 defining a vestibule 80.The hyolaryngeal complex 64 defines a rostrocaudal axis H_(RC) and ananterior-posterior axis H_(AP). For reference, and in general terms, thepharynx P (designated generally in the indicated direction) extends tothe hyolaryngeal complex 64, where respiratory and digestive pathwaysdiverge. This divergence is characterized by the pharynx P communicatingwith an esophagus E (designated generally in the indicated direction)posteriorly, where the UES 76 closes off the esophagus E from thepharynx P during breathing. Typically, the esophagus E conducts food andfluids to the stomach as previously described. In turn, air enteringfrom the pharynx P proceeds anteriorly through the laryngeal vestibule80 to a trachea T (designated generally in the indicated direction)during breathing.

With reference between FIG. 5A and FIG. 5B, during swallowing, thelaryngeal vestibule 80 is closed off while material is transportedposteriorly into the esophagus E. In particular, during a normalswallow, the hyolaryngeal complex 64 is lifted forward and upward. Theepiglottis 72 folds down to close off the laryngeal vestibule 80. Thismovement helps trigger relaxation of the UES 76 such that food or liquidcan pass into the esophagus E.

In a properly functioning swallow, the various movements areinvoluntarily coordinated to avoid substantial aspiration of a bolus ofliquid or solid matter. However, in cases of dysphagia, such deglutitionmovement is improperly timed and/or insufficient. For example, thehyolaryngeal complex 64 moves an insufficient amount upward and forward,the epiglottis 72 does not fold down sufficiently, and/or the UES 76does not sufficiently relax in some cases of dysphagia, such thataspiration during deglutition results. As described below, the system 20(FIG. 1) is usable to assist deglutition and, in particular, reduce orsubstantially eliminate aspiration during swallowing in dysphagiasufferers.

In view of the above overview of deglutition and dysphagia, variousembodiments of the following are described: implantation of the system20; various stimulation programs carried out by the system 20 and theirfeatures; stimulation of a single deglutition muscle and select musclegroups to artificially stimulate deglutition with the system 20; muscleactivation patterns and corresponding stimulation patterns forstimulating deglutition muscles; provision of user feedback in order tofacilitate timing of user initiated deglutition movement, for example;stimulation of deglutition musculature with the system 20 via associatednerves; and system feedback for controlling artificial deglutitionstimulation with the system 20, for example by modifying a stimulationprogram or programs.

Implantation of Deglutition Assistance Systems

With reference between FIG. 1, FIG. 5A, FIG. 5B, and FIG. 6, variousembodiment methods of implanting the system 20 are described. Foradditional reference, various ancillary procedures, for example,suturing incisions, irrigating surgical sites, applying prophylacticantibiotics, or checking bodily homeostasis, are clearly contemplated,but left from further discussion. In terms of use and configuration, thesystem 20 is optionally adapted to be portable and subcutaneouslyimplanted and/or otherwise born by a user 90 of the system 20 forsustained periods of time in some embodiments.

With that in mind, and with particular reference to FIG. 6, implantationof the system 20 generally includes disposing the controller 22, thesignal generator 24, and the power source 30 in the implantable housing32 as a single unit. One or more external devices, such as a hand switch116, are optionally connected to the controller 22 or are otherwise incommunication therewith for user-controlled deglutition stimulation, aswill be described in greater detail below. A first incision is made todefine a subcutaneous pocket 92 in the upper chest 94 and beneath theclavicle 96 of the user 90 of the system 20. The subcutaneous pocket 92is sized, shaped, and otherwise formed to maintain the implantablehousing 32. The implantable housing 32 is then disposed in thesubcutaneous pocket 92. Alternatively, in some embodiments, thecontroller 22, signal generator 24, and/or power source 30 areoptionally left external to the user 90, for example where the electrodearray 26 includes self-contained electrodes, for example similar toembodiments of the self-contained electrode 48 previously described.

A second incision, for example a modified apron incision with standardsuperior and inferior subplatysmal flaps, is formed in a neck 98 of theuser 90 at about a thyrohyoid-membrane level 100 of the neck 98. Thefirst and second incisions are connected by forming a first tunnelbetween the two incisions. The tunnel generally courses under the skinbetween the first and second incisions over the manubrium 102 of theuser 90.

In some embodiments, the electrode array 26 includes a first electricallead 104 a and a second electrical lead 104 b, each lead 104 a, 104 badapted to form an electrical connection between the electrode array 26and the signal generator 24. For example, where bilateral musclestimulation is desired, the second electrical lead 104 b is optionallysubcutaneously disposed on an opposite side of the neck 98 to the firstelectrical lead 104 a, with corresponding electrodes of the electrodearray 26 also subcutaneously positioned in an opposing manner in theneck 98. As referenced above, the electrical leads 104 a, 104 b areoptionally substantially similar to those provided for in the ExtensibleLead Applications.

Regardless, the electrical leads 104 a, 104 b each define first endregions 106 a, 106 b and second end regions 108 a, 108 b, respectively.The first end region 106 a of the first electrical lead 104 a is fedthrough the first tunnel to the subcutaneous pocket 92. In someembodiments, a third incision substantially similar to the secondincision is formed on an opposite side of the neck. A second tunnel isoptionally subcutaneously formed from the third incision to the firsttunnel, or directly from the third incision to the subcutaneous pocket92 formed via the first incision, though a variety of manners ofsubcutaneously positioning the electrical leads 104 a, 104 b arecontemplated. Regardless, the first end region 106 b of the secondelectrical lead 104 b is optionally fed through the second tunnel to thesubcutaneous pocket 92.

In some embodiments, the electrical leads 104 a, 104 b each branch outproximate the second end regions 108 a, 108 b (branching of the secondelectrical lead 108 b is hidden in the view of FIG. 6), such asbranching point BP of the first electrical lead 104 a. One or more ofthe points where each of the second end regions 108 a, 108 b branch outare optionally placed anterior to the sternocleidomastoid muscles of theuser 90, although other positions are also contemplated.

Although, as referenced above, FIG. 6 is indicative of bilateralimplantation of the electrode array 26 in the neck 98 of the user 90,unilateral implantation is also contemplated, for example using only thefirst electrical lead 104 a. In general terms, bilateral implantation isused to facilitate stimulation of bilateral deglutition musculaturealthough other scenarios are contemplated for bilateral implantation.One or more of the deglutition muscles 54 are identified, such as thethyrohyoid, the hyoglossus, the mylohyoid, and the geniohyoid, and/orany other deglutition muscles 54. Additionally, or alternatively, one ormore of the nerves 52 controlling the deglutition muscles 54 (motorfunction) and/or nerves 54 providing sensory functionality areidentified. For example, in some embodiments, visual confirmation and/orneurostimulation is used to identify the deglutition muscle(s) 54 and/ornerve(s) 52 of interest.

Following identification of the nerve(s) 52 and/or deglutition muscle(s)54, one or more electrodes of the electrode array 26, for example theelectrodes 26 a-26 c, are placed in stimulating communication with theselected deglutition muscle(s) 54, either directly or via the nerve(s)52 related to or otherwise controlling the selected muscle(s) 54. Theelectrode array 26 is optionally secured in place using a suture,surgical clamp, or other means as appropriate. In some embodiments,placing the electrode array 26 in stimulating communication withdeglutition muscle(s) 54 includes: fixing one or more electrodes of theelectrode array 26 to a surface of a one or more of the deglutitionmuscles 54; inserting one or more electrodes into one or moredeglutition muscles 54; and/or placing one or more electrodes instimulating communication with one or more of the nerves 52 causingactivation of one or more of the selected deglutition muscle(s) 54.

At some point, the second ends 108 a, 108 b of the electrical leads 104a, 104 b are secured to the implantable housing 32 and placed incommunication with the signal generator 24. In turn, the first ends 106a, 106 b of the electrical leads 104 a, 104 b are connected toelectrodes of the electrode array 26. It should be noted that in someembodiments, electrodes of the electrode array 26 can also serve sensingfunctionality, for example serving as a sensor in the sensor array 28.Also of note, the sensor array 28 is optionally implanted withsubstantially similar techniques to those used in association with theelectrode array 26. To provide additional understanding, some embodimentmethods of implanting the sensor array 28 are described below inassociation with the sensors 28 a-28 c.

In particular, a fourth incision is optionally made at a chin bone, andmore specifically the mental protuberance 110 of the mandible of theuser 90. The first sensor 28 a is subcutaneously affixed to the mentalprotuberance 110, for example with an adhesive, suture, bone anchor, orother means. The first sensor 28 a is optionally connected to one of thefirst and second electrical leads 104 a, 104 b. In other embodiments,the first sensor 28 a is connected to a third electrical lead 112, suchas a flexible, extensible electrical lead, coursing over the manubrium102 in a substantially similar manner to the first and second electricalleads 104 a, 104 b.

With reference between FIG. 5A, FIG. 5B, and FIG. 6, the second sensor28 b is optionally inserted through the second or third incision forexample, or a fifth incision is optionally made in the neck 98 of theuser 90 with the sensor 28 b subcutaneously positioned through the fifthincision. The second sensor 28 b is optionally secured to a deglutitionstructure 56, such as the hyolaryngeal complex 64, for example. In someembodiments, the second sensor 28 b is secured relative to the hyoidbone 70, the epiglottis 72, or any laryngeal cartilages, including athyroid cartilage, a cricoid cartilage, an arytenoid cartilage, acuneiform cartilage, and/or a corniculate cartilage, for example.Additionally, or alternatively, the second sensor 28 b is optionallysecured relative to the UES 76.

In some embodiments, the second sensor 28 b is oriented substantiallyparallel to the rostro-caudal axis H_(RC) and anterior-posterior axisH_(AP) of the hyolaryngeal complex 64 or a particular component thereof.Where applicable, the second sensor 28 b is connected to an electricallead, for example the second sensor 28 b is optionally connected tofirst electrical lead 104 a. From this, it should be understood that theelectrical leads 104 a, 104 b optionally serve multiple purposes,including, for example, conveying stimulating energy to the electrodearray 26 along with conveying power to and/or conveying sensorinformation from the sensor array 28.

With particular reference to FIG. 6, in some embodiments, the thirdsensor 28 c is secured relative to the implantable housing 32 of thesystem 20. For example the third sensor 28 c is optionally implantedprior to, concurrently with, or following, implantation of the housing32. In some embodiments the third sensor 28 c is secured on theimplantable housing 32 or otherwise secured such that the third sensor28 c is at a substantially set distance from the implantable housing 32and in communication with the controller 22 and/or the signal generator24.

Following implantation of the system 20, various testing and/oroptimization of the system 20 is performed as desired. In someembodiments, the system 20 performs a self-configuration operation bystimulating user deglutition using the electrode array 26 and receivinginformation from the sensor array 28 to optimize deglutition stimulationas described in greater detail below. Following evaluation of the sensorarray information, the system 20 modifies a system configuration, forexample by changing a stimulation program, to better control userdeglutition. In other embodiments, the system 20 is manually configuredby a technician or other appropriate personnel. Implantation informationregarding implantation of the system 20 is also optionally recorded. Forexample information relating to electrode type/placement, sensortype/placement, system testing results, and/or other pertinentinformation is optionally stored remotely or directly in memoryassociated with the system 20.

Stimulation Program Initiation and Selection

With reference to FIG. 1, following implantation, the system 20 is usedto stimulate a component of user deglutition, according to one or morestimulation programs. In particular, the system 20 is adapted forstimulating multiple deglutition responses in the user 90 (FIG. 6) inorder to assist one or more components of user deglutition withoutsubstantial aspiration. As referenced above, the system 20 optionallystimulates one or more components of user deglutition as part of amethod of configuring the system 20, as part of a therapeutic method forteaching the user 90 how to swallow, and/or as part of a method ofsustained assistance over an extended period of time, for example.

The system 20 generally activates one or more of the deglutition muscles54 according to one or more stimulation programs. For example, thecontroller 22 optionally stores one or more stimulation programs andoperates the signal generator 24 according to the desired deglutitionprogram to send stimulating energy to the electrode array 26 foractivating the one or more deglutition muscles 54. In some embodiments,the stimulation programs include an active feeding program forstimulating deglutition of at least one of food and drink withoutsubstantial aspiration and a passive user secretion maintenance programfor stimulating deglutition of user secretions without substantialaspiration. The active feeding program is optionally further dividedinto specific bolus deglutition program categories according to a boluscharacteristic, for example a specialized liquid deglutition program anda specialized solid deglutition program, specialized deglutitionprograms optimized according to bolus volume or consistency, as well asothers, as desired.

Initiation of the active feeding program is optionally under “usercontrol.” In particular, the active feeding program, including anyspecialized deglutition programs, is optionally initiated in response toa user feeding request prompt, for example via an external hand-heldswitch sensor, such as a hand switch 116 as shown generally in FIG. 6,or via voice command, motion sensor, or one or more of the sensors ofthe sensor array 28, either “wired” or otherwise in communication withsystem 20 as described above, for example via radio frequencycommunication. Thus, in some embodiments, the user is able to providethe system 20 with a feeding request prompt in order to initiate theactive feed program.

In some embodiments, the user 90 is able to initiate the active feedingprogram and sustain deglutition muscle stimulation with the system 20for a desired period or duration, for example by holding down the handswitch 116 for the desired duration of stimulation. Additionally,stimulation intensity is optionally the subject of user control, forexample according to a degree of depression of the hand switch 116 orother sensor. It is also contemplated that a safety override beprovided, wherein after a preset time period of substantially continuousdeglutition stimulation, for example twenty seconds, or after a certainamount of stimulating energy has been delivered, for example as measuredin joules, the system 20 automatically interrupts further stimulation.Although some embodiments include user-controlled initiation of theactive feeding program, it should also be understood that the system 20optionally automatically senses when a user is eating or desires toswallow, for example using one or more sensors of the sensor array 28.Also, in some embodiments, the user 90 provides user input, for exampleusing a hand switch, as to what type of bolus and/or correspondingdeglutition program should be run by the system 20.

As alluded to above, the active feeding program is optionally optimizedfor liquid or solid bolus consumption, consumption of boluses havingdifferent bolus volumes, or consumption of boluses having differentbolus consistencies, for example, via provision of specialized programs.As will be described, stimulation according to such specialized programsis optionally modeled to exhibit a deglutition response characteristicof “normal” liquid-like or solid-like deglutition according to suchconditions, e.g., deglutition of a liquid by a person not suffering fromdysphagia.

In some embodiments, the user secretion maintenance program operatespassively, or as a background program. In particular, the user secretionmaintenance program is adapted to automatically, periodically stimulatedeglutition of user secretions, such as saliva or mucous. There isevidence that an average adult produces between about 500 ml and about1500 ml of saliva each day. Providing an automatic maintenance programfacilitates disposing such user secretions without the user 90substantially aspirating those secretions. Periodicity, i.e., the timingbetween deglutition sequences initiated according to the user secretionmaintenance program, is optionally determined via observation of aparticular individual, for example an average time that a human or otheranimal exhibits between secretion deglutition, or periodicallystimulates deglutition as otherwise selected. The user secretionmaintenance program can also be operated as part of a “night mode”operation setting of the system 20. For example, the user secretionmaintenance program optionally starts and ends during a particularperiod, such as from 10 p.m. to 6 a.m., when the user 90 is in asubstantially reclined position or state, or according to othercriteria, for example. The user secretion maintenance program optionallyoperates continuously in the background until the active feeding programis initiated. As previously alluded to, the user secretion maintenanceprogram includes stimulation patterns optimized for muscle activationassociated with secretion deglutition in some embodiments.

Single Muscle Stimulation and Select Muscle Group Stimulation

With reference to FIG. 1, FIG. 5A, and FIG. 5B, while variousembodiments include using a plurality of the deglutition muscles 54 tostimulate user deglutition, in some embodiments, the system 20 isadapted to stimulate one or more components of user deglutition usingonly a single one of the deglutition muscles 54 throughout a completeswallowing act. In particular, the electrode array 26 is placed instimulating communication with a single one of the deglutition muscles54. The single deglutition muscle is activated by placing one or moreelectrodes in contact with the single muscle, for example, although thesingle deglutition muscle can also be directly stimulated via one ormore nerves controlling the single muscle, with one or more electrodesplaced in stimulating communication with the single deglutition musclevia one or more of the nerves 52 to stimulate that single muscle.

Thus, in some embodiments a single deglutition muscle is artificiallystimulated with the system 20 according to a stimulation program tocause a desired component of a complete deglutition act to occur.Although the single deglutition muscle is the only one of thedeglutition muscles 54 directly targeted from stimulation via theelectrode array 26 during the complete deglutition act, it iscontemplated that some stimulating energy might inadvertently orotherwise indirectly delivered to other ones of the deglutition muscles54, for example by current bleed or current being transmitted throughthe single deglutition muscle.

With reference to FIG. 5B in particular, and as alluded to above, sometypes of dysphagia aspiration arise as a result of an inability toactivate lifting of the hyolaryngeal complex 64 to a sufficient degreeand/or with appropriate timing, as well as an inability to sufficientlyrelax the UES 76 (FIG. 5A). Indeed, there is evidence that a substantialportion of dysphagia-related aspiration arises as a result of suchdefects in deglutition. In some embodiments, the hyolaryngeal complex 64is sufficiently lifted by directly stimulating a single one of thehyoglossus 54 e, the posterior belly of the digastric 54 d, or thestylohyoid 54 f, each of those muscles being generally represented inFIG. 5B according to a direction of movement the respective deglutitionmuscle 54 exerts hyolaryngeal complex 64. Thus, with reference to FIG.5B and the foregoing, associated description, the method of stimulatinga single muscle is particularly advantageous in some embodiments wherethe user 90 is characterized as being capable of autonomously stretchingthe UES 76 a sufficient amount in combination with the lifting and/orforward motion of the hyolaryngeal complex 64 provided by singledeglutition muscle stimulation using the system 20 (FIG. 1). In someembodiments, a presence of sufficient, autonomous UES stretching,movement, and/or opening force is determined using the sensor array 28(FIG. 1), as subsequently described.

With reference to FIGS. 5A and 5B, in some other embodiments, the system20 (FIG. 1) is adapted to stimulate one or more components of userdeglutition using a plurality of the deglutition muscles 54, such as oneor more of those specifically described. The system 20 can operate toengender synergistic muscle movement or otherwise produce synergisticlaryngeal elevation and opening of the upper esophageal sphincter usingthe plurality of deglutition muscles 54. The PCT App. Pub. WO2004/028433 to inventors Ludlow et al. and entitled “Methods and Devicesfor Intramuscular Stimulation of Upper Airway and Swallowing MuscleGroups” (published Apr. 8, 2004) describes some systems and methods forproducing synergistic laryngeal elevation and opening of the UES, thecontents of which are incorporated herein by reference.

In some embodiments, the system 20 is further adapted to stimulate atargeted group of the deglutition muscles 54 including the mylohyoid,the geniohyoid, and the thyrohyoid in addition to at least one of theanterior belly of the digastric and the hyoglossus of the user 90. Bystimulating the mylohyoid, the geniohyoid, and the thyrohyoid inaddition to one or both of the anterior belly of digastric and thehyoglossus, it is believed the system 20 can artificially inducecompleted deglutition with the targeted group without any otherartificial intervention.

Muscle Activation Patterns and Stimulation Patterns

With reference to FIG. 7 several muscle activation patterns are shown.In particular, according to some EMG studies of muscle activation duringdeglutition, natural muscle activation occurs over a series ofsequential, overlapping patterns. FIG. 7 is illustrative of EMGmeasurements of muscle activation patterns in areas of a mouth, pharynx,and larynx in each of monkey, cat, and dog during deglutition asdescribed in R. W. Doty & J. F. Bosma, An electromyographic analysis ofreflex deglutition, 19 J. NEUROPHYSIOLOGY 44-60 (1956), the contents ofwhich are incorporated herein by reference.

A “leading complex” of muscle activation patterns includes mylohyoidactivation pattern 150, geniohyoid activation pattern 152, posteriorintrinsic tongue muscles activation pattern 154, palatopharyngeusactivation pattern 156, and superior constrictor activation pattern 158.Also included are activation patterns of the palatoglossus,styloglossus, and stylohyoid (not shown) as part of the “leadingcomplex.” The leading complex activation patterns initiate deglutition,showing concurrent elevated muscle activity for between about 250milliseconds and about 500 milliseconds.

Other delayed muscle activation patterns show inhibited onset ofelevated muscle activity, including thyrohyoid muscle activation pattern160, thyroarytenoid activation pattern 162, middle constrictoractivation pattern 164, cricothyroid activation pattern 166, inferiorconstrictor activation pattern 168, and diaphragm activation pattern170. In fact, the inferior constrictor activation pattern 168 showsdeferred muscle activation until elevated muscle activity of the leadingcomplex is nearly over. Several of the leading complex and delayedactivation patterns exhibit features such as baseline activation,decreased transient activation, increasing activation ramping, and/ordecreasing activation ramping. For example, the mylohyoid activationpattern 150 shows baseline activation segments 180 a, 180 b, decreasedtransient activation segments 182 a, 182 b, an increasing ramp segment184, a decreasing activation ramp 186, and an elevated activationsegment 188.

In some embodiments a stimulation program or programs are determined orset according to activation patterns, such as those described above,including activation of a leading muscle complex and delayed activationpatterns for other deglutition muscles as desired. In order to obtainone or more activation patterns for the deglutition muscle(s) 54,averaged natural deglutition muscle stimulation patterns are optionallydetermined from a test group such as a group of healthy, dysphagia-freetest subjects. The stimulation program then sets or drives deglutitionmuscle stimulation to imitate the averaged natural deglutition muscleactivation patterns. In some embodiments, individual natural deglutitionmuscle stimulation patterns for a particular individual are measured orcalculated to determine a customized activation pattern. In someembodiments, the stimulation program then sets or drives deglutitionmuscle stimulation to the customized pattern. In other embodiments,theoretical natural deglutition muscle stimulation patterns are derivedfrom empirical data, qualitative observation, user feedback, measurementof actual bolus deglutition with various applied stimulation patterns,and/or via other means. Such theoretical and/or iterative evaluationtechniques may be particularly advantageous where the user 90 is asufferer of dysphagia and appropriate natural deglutition stimulationpatterns are not directly measurable from the user 90.

Furthermore, particular categories of deglutition are optionallymeasured or modeled, for example liquid deglutition, solid deglutition,and/or user secretion deglutition. In at least this manner, specializedfeeding programs, such as a specialized liquid or solid deglutitionprograms, user secretion maintenance programs, or even changes indeglutition according to body position or environment, for example whenthe user 90 is in a reclined position, is at high altitude, is underwater, and others, are optionally identified by measuring or modelingdeglutition muscle activation when the user 90 or test group isswallowing such boluses and/or is in the states described.

With reference between FIGS. 1 and 7, in some embodiments, the system 20uses one or more of the stimulation programs to stimulate a plurality ofthe deglutition muscles 54 to imitate natural deglutition muscleactivation patterns. For example, some embodiments include using thesignal generator 24 to cause the electrode array 26 to stimulate thedeglutition muscles 54 with a group of sequential and overlappingelectrical pulse trains in order to activate the deglutition muscles 54similarly to sequential, overlapping patterns of muscle activation, suchas those illustrated in FIG. 7. In some embodiments, the group ofsequential and overlapping electrical pulse trains includes at least oneasymmetric, biphasic waveform.

Thus, in some embodiments, the stimulating electrical pulse trainsthemselves imitate the muscle activation patterns, or have somewhatsimilar amplitude and timing to the muscle activation patterns. In otherembodiments, regardless of whether electrical pulses delivered by thesystem 20 are delivered to the deglutition muscles 54 (FIG. 5A) assequential and overlapping pulses, the stimulating energy patterndelivered by the electrode array 26 is configured such that resultantactivation patterns of the plurality of deglutition muscles 54 imitateor are similar to a desired set of activation patterns. Furthermore,analogously to the muscle activation patterns described above, thesystem 20 optionally delivers one or more electrical pulses defining oneor more stimulation pattern features, such as baseline segments,decreased transient segments, increasing ramps, decreasing ramps and/orothers, such features imitating corresponding muscle activation patternfeatures, or others.

In some embodiments, baseline segments are included in the stimulationpatterns or baseline activation segments are otherwise simulated toadjust muscle tension before triggering a component of deglutitionassociated with a particular deglutition muscle 54. In some embodiments,baseline segments in a stimulation program optionally serve to placedeglutition musculature of the user 90 in a state of partial activationprior to at least one of activation of the partially activateddeglutition musculature via autonomous user stimulation and artificialactivation of the partially activated musculature via the system 20. Asevidenced by FIG. 7, many of the deglutition muscles 54 exhibit baselineactivity prior to full muscle activation. Incorporating a baselinestimulation segment in the stimulation program pattern for a deglutitionmuscle can serve various roles, including, for example, adjusting muscleslack and hyolaryngeal position in preparation for deglutition and/orproviding proprioceptive and tactile user feedback to a central nervoussystem of the user 90.

FIG. 7 also evidences that many of the deglutition muscles 54 (FIG. 5A)exhibit decreased transient activity before and/or after full muscleactivation. In some embodiments, decreased transient segments are alsopresent in stimulation program patterns or decreased transientactivation is otherwise simulated. In some embodiments, decreasedtransient activation serves to inhibit baseline activation activity asdescribed above, with such inhibition occurring just prior to and/orfollowing full activation of one or more of the deglutition muscles 54.

User Feedback and Deglutition Timing with Artificial DeglutitionStimulation

With reference to FIGS. 1 and 5, in some embodiments, user feedbackhelps the user 90 time autonomous deglutition efforts with theartificial stimulation provided by the system 20. In particular, someembodiments include the user 90 autonomously providing some of themovement required for deglutition in response to the user feedback, withthe system 20 also providing stimulation for remaining deglutitionmovement to help prevent aspiration as desired. For example, the user 90is optionally provided with a subthreshold, baseline signal prior touser deglutition, such as the baseline signals described above, whichprovides proprioceptive user feedback. In turn, artificial stimulationof deglutition musculature with the system 20 is coordinated with theuser feedback, for example at a desired timing or delay betweeninitiation of the baseline signal and initiation of a stimulating signalby the system 20. Additionally, or alternatively, the user feedbackoptionally can also serve to help “retrain” the user 90 how to swallow,such that the user feedback is part of a therapeutic program.

In some embodiments user feedback is additionally or alternativelyprovided by stimulating sensory mucosa (not shown) of at least one ofthe mouth and throat of the user 90, such as sensory mucosa associatedwith the hyolaryngeal complex 64 and/or pharynx P to provide tactile,sensory feedback to the user 90. In particular, one or more electrodesof the electrode array 26 are placed in stimulating communication withsensory mucosa of the hyolaryngeal complex 64 or the pharynx P, forexample. During artificial deglutition stimulation, the system 20stimulates the sensory mucosa to provide tactile user feedback asdesired. It should be understood that it is contemplated that anysensory mucosa of the deglutition components 50 could be stimulated toprovide user feedback. Also, as described above, other embodimentsalternatively or additionally include using subthreshold, baseline orother low-level muscle stimulation signal with the electrode array 26 toprovide proprioceptive feedback. In some embodiments, sensory feedbackis provided by placing one or more electrodes in direct stimulatingcommunication with one or more of the nerves 52.

Artificial Deglutition Muscle Stimulation Via Nerves

As referenced above, while the system 20 is optionally adapted todeliver stimulating energy to one or more of the deglutition muscles 54by placing contacts of the electrode array 26 in or on deglutitionmusculature, some embodiments also include stimulating one or moredeglutition muscles 54 via the nerves 52 as will be described withreference between FIG. 1, FIG. 5A, and FIG. 8. For example, the variousstimulation programs and/or muscle activation patterns described aboveare optionally delivered via stimulation of deglutition musculature bystimulating the nerves 52 with the electrode array 26 or by stimulatingthe deglutition muscles 54 using electrodes implanted on (epimysialelectrodes) or in (intramuscular electrodes) the deglutition muscles 54,for example. With that in mind, some embodiments including artificialdeglutition muscle stimulation via the nerves 52 are described ingreater below.

With particular reference to FIG. 8, a schematic illustration of theelectrode array 26 placed in stimulating communication with the firstand second nerves 52 a, 52 b is shown. For reference, FIG. 8 illustratesvarious deglutition components 50 previously described, and alsopresents a schematic view of a tooth 200 and a tongue 210 of the user90. In some embodiments the first electrode 26 a of the electrode array26 is adapted for stimulating nerves, for example being substantiallysimilar to embodiments of the nerve cuff electrode 40 (FIG. 3)previously described. The second electrode 26 b is similarly configured,also optionally being a nerve cuff electrode substantially similar toembodiments of the nerve cuff electrode 40. For reference, one or bothof the first and second nerves 52 a, 52 b optionally provide sensoryand/or motor functionality, with deglutition muscle response occurringas a result of sensory stimulation or motor function stimulation.

With additional reference to FIGS. 1 and 5, in some embodiments, thesystem 20 is adapted for selectively stimulating nerve fascicles of thenerves 52 in order to activate one or more of the deglutition muscles 54to assist with any one or more of the stages of deglutition. For adiscussion of selective muscle stimulation and acceptable electrodetypes see, for example, M. D. Tarler & J. T. Mortimer, Elective andindependent activation of four motor fascicles using a four contactnerve-cuff electrode, 12(2) IEEE TRANSACTIONS ON NEURAL SYS. REHAB.ENG'G 251-257 (2004); W. M. Grill & J. T. Mortimer, Inversion of thecurrent-distance relationship by transient depolarization, IEEETRANSACTIONS ON BIOMEDICAL ENG'G 1-9 (1997); U.S. Pat. No. 5,344,438(issued Sep. 6, 1994) (inventors Testerman et al.) (entitled, “CuffElectrode”); and U.S. Pat. No. 6,907,293 (issued Jun. 14, 2005)(inventors Grill et al.) (entitled, “Systems and Methods for SelectivelyStimulating Components in, on, or near the Pudendal Nerve or ItsBranches to Achieve Selective Physiologic Responses”), the contents ofeach of which are incorporated herein by reference. In general terms,selective stimulation can be advantageous where non-selectivestimulation of one or more of the nerves 52 would result in impropertiming or interfere with other stages of swallowing. For example,stimulation of the hypoglossal nerve without selective fasciclestimulation could result in early activation of the styloglossus and theintrinsic muscles of the tongue, which would otherwise interfere withthe oral stage of swallowing.

Regardless, in some embodiments, each of the first and second electrodes26 a, 26 b is adapted to allow selective stimulation of nerves and isplaced in stimulating communication with one of the nerves 52, and thusone or more of the deglutition muscles 54. In some embodiments, thefirst electrode 26 a is disposed about the first nerve 52 a, which isthe hypoglossal nerve, for example. In turn, the second electrode 26 bis disposed about the second nerve 52 b, which is the mylohyoid nerve,for example. In particular, the first electrode 26 a is located on thefirst nerve 52 a to deliver stimulating energy to the nerve fascicles 60of first nerve 52 a for stimulating or otherwise causing activation ofone or more of the geniohyoid, hyoglossus, thyrohyoid, omohyoid,sternothyroid, sternohyoid, genioglossus, and styloglossus muscles. Inturn, the second electrode 26 b is located on the second nerve 52 b todeliver stimulating energy to the nerve fascicles 62 of the second nerve52 b for stimulating or otherwise causing activation of one or more ofthe mylohyoid and a digastric muscle, for example. In particular, someembodiments include selectively stimulating activation of one or more ofthe hyoglossus, geniohyoid, and thyrohyoid muscles by selectivelystimulating fascicles of the first nerve 52 a and selectivelystimulating activation of one or more of the mylohyoid and anteriorbelly of the digastric muscles by selectively stimulating fascicles ofthe second nerve 52 b.

In some embodiments where bilateral stimulation desired, the third andfourth electrodes 26 c, 26 d are placed on an opposite side of the user90 in communication with second hypoglossal and mylohyoid nervesopposite the first and second nerves 52 a, 52 b, for example. The thirdand fourth electrodes 26 c, 26 d are optionally substantially similar inform and operation to the first and second electrodes 26 a, 26 b, andthus are left from further discussion.

Regardless, where selective stimulation is appropriate, the controller22 is adapted to operate the signal generator 24 to selectivelystimulate one or more fascicles of the nerves 52 with the electrodearray 26, such as the fascicles 60 of the first nerve 52 a and/or thefascicles 62 of the second nerve 52 b. Some embodiments includeselectively stimulating the first fascicle 60 a of the first nerve 52 a,selectively stimulating the second fascicle 60 b of the first nerve 52a, and selectively stimulating the third fascicle 60 c of the firstnerve 52 a, where each of the first, second, and third fascicles 60 a-60c control activation of a different deglutition muscle than the others.Similarly, embodiments include selectively stimulating the firstfascicle 62 a of the second nerve 52 b and selectively stimulating thesecond fascicle 62 b of the second nerve 52 b, the first fascicle 62 acontrolling activation of a different deglutition muscle than the secondfascicle 62 b, and so forth.

In order to accomplish selective fascicle stimulation, some embodimentsinclude using the signal generator 24 to deliver subthreshold,rectangular current pulses, or current ramps to partially depolarizenerve fibers of the first and/or second nerves 52 a, 52 b using thefirst and/or second electrodes 26 a, 26 b. As used herein, the term“subthreshold” is indicative of an insufficient amount of stimulation toresult in full muscle activation. Additionally, for reference, and inbrief, stimulation of the nerves 52 is generally characterized by astrength-to-distance relationship, where fascicles closer to a source ofstimulating energy, for example an electrical current pulse deliveredfrom the electrode array 26, are stimulated first and/or to a greaterextent. By using subthreshold, rectangular current pulses or ramps, thestrength-to-distance relationship is optionally inverted, such thatfascicles can be selectively stimulated by partially depolarizing acorresponding nerve. In other words, the system 20 can be configured toselectively stimulate a fascicle or group of fascicles more distant fromthe stimulating electrode than a closer group of fascicles, and prior tothe closer group of fascicles, by depolarizing the nerve.

Additionally or alternatively, the strength-to-distance relationshipdescribed above is taken advantage of in some embodiments by placingelectrode contacts at various positions on or around one or more of thenerves 52. By delivering a standard current pulse, for example a 100-μsrectangular current pulse, to a particular location on the one or morenerves 52, nerve fascicles closest to a particular contact arestimulated first or to a sufficient degree to result in muscleactivation of one or more of the deglutition muscles 54. Thus,selectivity is also optionally accomplished by placing contacts atvarious locations about a nerve more proximate a fascicle group that isto be stimulated.

As yet another, non-exclusive means for accomplishing selective fasciclestimulation, current steering techniques are optionally employed. Insome embodiments, the first and second electrodes 26 a, 26 b aresubstantially similar to embodiments of the nerve cuff electrode 40(FIG. 3) previously described, with each of the first and secondelectrodes 26 a, 26 b including a plurality of radially positionedmonopolar contacts, for example four monopolar contacts per electrode,although bipolar contacts are contemplated in some embodiments. Thesignal generator 24 is configured to operate over multiple channels todeliver varying amounts of stimulating energy to each of the radiallypositioned contacts. In particular, subthreshold steering currents areapplied about the nerve, for example the first nerve 52 a, at differentamplitudes in order to shape an electrical field applied to the nerve asdesired. The subthreshold steering currents do not necessarily result innerve stimulation. In particular, in some embodiments, the steeringcurrents are applied about one of the nerves 52, for example the firstnerve 52 a, to direct another, stimulus pulse or series of pulsesgenerated with the first electrode 26 a or another electrode to adesired region of nerve activation. In other words, the steeringcurrents are used to direct an additional stimulating current pulse orpulses to a selected fascicle or group of fascicles.

Additionally, stimulation pattern waveforms are optionally selected toimprove an ability to selectively stimulate nerve fascicles of thenerves 52. For example, short duration current pulses have beenidentified as increasing stimulation threshold differences between nervefibers of different diameters. While several mechanisms foraccomplishing selective fascicle excitation/stimulation have beendescribed above, it should be understood that other mechanisms are alsocontemplated, including electrical blocking of nerves/nerve fascicles.

In some other embodiments, the first and second electrodes 26 a, 26 bare located along the nerves 52 at a location where selectivestimulation of nerve fascicles in order to activate desired deglutitionmusculature is not required.

In particular, the first and second electrodes 26 a, 26 b are optionallylocated along a nerve branch rather than a nerve trunk, for example aperipheral branch of the hypoglossal nerve, sufficiently proximate oneor more of the deglutition muscles 54, such that a desired timing ofactivation of a desired set of the deglutition muscles 54 isaccomplished without selectively stimulating nerve fascicles. Thus, theelectrode array 26 additionally or alternatively includes a plurality ofelectrodes disposed along, and in stimulating communication with, aplurality of nerves in order to effectuate deglutition musculaturestimulation without selective fascicle stimulation.

System Feedback

With reference to FIGS. 1 and 6 and turning back to the sensor array 28,in some embodiments, the sensor array 28 provides the system 20 meansfor operating with system feedback. For example, the stimulationprograms described above are optionally initiated, modified, orotherwise adapted according to sensor input information received by thecontroller 22. Various sensors and their use are described below. Forexample, in some embodiments, the sensor array 28 includes sensorsconfigured and placed, for example subcutaneously and/orintramuscularly, to provide EMG feedback to the system 20. Such EMGfeedback is optionally used to drive a stimulation program to apredetermined, optimal muscle activation pattern as measured via the EMGfeedback.

In some embodiments, the sensor array 28 includes one or more forcesensors, such as strain gauges, providing force information to thecontroller 22. According to some applications, one or more of the straingauges are attached to one or more deglutition muscles 54 to provideforce information during various states of muscle activation. Forexample, in some embodiments, the first sensor 28 a is a strain gaugeand is attached to the UES 76 to provide information relating to anopening force applied to the UES 76. Such force information isoptionally used by the system 20, and in particular the controller 22,to optimize a stimulation program or otherwise provide system feedbackinformation for modifying deglutition muscle stimulation.

In still other embodiments, the sensor array 28 includes one or morepositional sensors, such as accelerometers providing such information asacceleration, velocity, or position. In some embodiments the firstsensor 28 a is a three-axis accelerometer providing head positioninformation and is optionally secured relative to the chin, for examplethe mental protuberance 110. With additional reference to FIG. 5A, thesecond sensor 28 b, in turn, is a three-axis accelerometer securedrelative to one or more deglutition components 50, such as a portion ofthe hyolaryngeal complex 64 of the user 90. For example, the secondsensor 28 b is optionally secured relative to the hyoid 70 or otherlaryngeal cartilage, such as the thyroid cartilage. In some embodiments,the second sensor 28 b is optionally oriented parallel to theanterior-posterior and rostro-caudal axes H_(AP), H_(AR) of thelaryngeal complex 64 or components thereof. Still yet, the third sensor28 c is optionally a three-axis accelerometer secured relative to theimplantable housing 32.

In some embodiments, overall body position information of the user 90 isprovided by the sensor array 28, and in particular the third sensor 28c. Movement of the hyolaryngeal complex 64 or components thereofrelative to a torso of the user 90 is provided using combined positionalinformation from the second and third sensors 28 b, 28 c. Thisinformation relating to relative positions of the torso and hyolaryngealcomplex 64 can then be used to optimize deglutition stimulation with thesystem 20 for a desired relative movement of the deglutition structures54, such as the hyolaryngeal complex 64 or portions thereof. In turn,neck flexion information is optionally provided using combinedpositional information from the sensor 28 a secured relative to the chinand the second sensor 28 b secured relative to the laryngeal complex 64or portions thereof. In this manner, the system 20 compensates for neckflexion during deglutition stimulation. Additionally or alternatively,in some embodiments, the sensor array 28 provides information related towhether the user 90 is in a reclined state, for example in order todetermine whether to select the user secretion maintenance program or tooptimize swallowing for a reclined position.

Although combined utilization of positional information is contemplatedas referenced above, non-combined positional information from a singleposition sensor, such as a three-axis accelerometer is also optionallyused to optimize or otherwise modify deglutition stimulation with thesystem 20. In some embodiments, information relating to whether thehyolaryngeal complex 64 is being adequately lifted and moved forward isobtained where a standard orientation of the body of the user 90 isassumed and an accelerometer, for example one of the three-axisaccelerometers as previously referenced, is oriented parallel to theanterior-posterior and rostro-caudal axes H_(AP), H_(AR) of thehyolaryngeal complex 64 or components thereof, for example.

In still other embodiments, the sensor array 28 includes one or morepressure sensors, for example sensors for measuring intrapharyngealpressure. For example, intrapharyngeal pressure is optionally measuredas an indicator of effective deglutition stimulation and/or artificialresponse.

With reference between FIG. 1, FIG. 5A, and FIG. 6, in some embodiments,the sensor array 28 alternatively or additionally includes one or moredisplacement sensors providing displacement information, such assonomicrometers (not shown) including ultrasonic sensing and generatingcrystals to measure distance between crystals. One or more of the first,second, and third sensors 28 a-28 c are optionally sonomicrometersattached to one or more components of the hyolaryngeal complex 64. Insome embodiments, the sensors 28 a-28 c are used to provide displacementinformation relating to lengths of one or more of the deglutitionmuscles 54. In particular, displacement of various deglutitionstructures 56 can be derived, or otherwise estimated, using such overallmuscle length information. Additionally or alternatively, suchdisplacement sensors are used in a substantially similar manner to thepositional sensors as described above in order to optimize or otherwisemodify stimulation programs. For example, relative positions of thehyolaryngeal complex 64, including the hyoid 70, the chin, and/or thethyroid cartilage, are optionally provided by the sensor array 28 toadjust deglutition stimulation. In some embodiments, a thyroid-hyoid gapis determined using the displacement sensors with stimulation of thethyrohyoid muscle applied proportionally to the thyroid-hyoid gap.

In sum, and in accordance with the understanding provided by the textualdescriptions, figures, and the accompanying claims, systems forassisting deglutition and methods for constructing and using systems forassisting deglutition have been disclosed, taught, and suggested, withsuch systems and methods serving a variety of purposes, such as helpingprovide deglutition with reduced aspiration. Such systems and methods ofassisting deglutition have applicability for use with at least humans orother animals and are useful as either partially or entirely external ornon-implanted systems, as well as entirely implanted or internalsystems. Although the present invention has been described withreference to various embodiments, workers skilled in the art willrecognize that changes can be made in form and detail without departingfrom the spirit and scope of the present invention. For example,although systems and methods associated with deglutition have beendescribed herein, it should also be understood that principles of thepresent invention are applicable to other areas of muscle stimulation,for example speech, breathing, or other types of bodily movement.

1. A system for assisting user deglutition without substantialaspiration, the system comprising: an electrode array adapted to besubcutaneously positioned in stimulating communication with deglutitionmusculature; a sensor array adapted to be subcutaneously positioned forproviding deglutition information; a signal generator electronicallyconnected to the electrode array for providing a stimulating signal tothe electrode array; and a controller electronically connected to thesensor array for receiving the deglutition information andelectronically connected to the signal generator to prompt operation ofthe signal generator in delivering the stimulating signal to cause acomponent of deglutition to occur, wherein the controller is programmedto store a plurality of specialized deglutition programs, eachspecialized deglutition program including at least one deglutitionmuscle stimulation pattern, receive an indication of a characteristic ofa bolus to be consumed by a user and select a desired deglutitionprogram from the plurality of specialized deglutition programs basedupon the characteristic, wherein the controller is further adapted toactively modify the stimulating signal delivered by the signal generatorbased upon the desired deglutition program.
 2. The system of claim 1,wherein the deglutition information is selected from the groupconsisting of: hyolaryngeal complex position information, overall userbody position information, upper esophageal opening force information,upper esophageal displacement information, user chin positioninformation, user head position information, user torso positioninformation, deglutition muscle length information, and combinationsthereof.
 3. The system of claim 1, wherein the sensor array includes atleast one of an accelerometer, a force gauge, a strain gauges, an EMGsensor, a displacement sensor, a piezoelectric ultrasonic transducer, apressure sensors, and combinations thereof.
 4. The system of claim 1,wherein the bolus characteristic includes at least one of bolus volumeand bolus consistency.
 5. The system of claim 1, wherein the boluscharacteristic includes whether the bolus is liquid-like or solid-like.6. The system of claim 1, wherein at least one of the specializeddeglutition programs includes a group of predetermined, sequential, andoverlapping pulse trains.
 7. The system of claim 6, wherein at least oneof the group of predetermined, sequential, and overlapping pulse trainsincludes a signal ramp at a beginning of the at least one pulse train.8. The system of claim 6, wherein at least one of the group ofpredetermined, sequential, and overlapping pulse trains includes atleast one asymmetric, biphasic waveform.